FDA approves amivantamab for head and neck cancer

Accelerated approval follows a 42% response rate in 102 patients previously treated with chemotherapy and immunotherapy.

By
Mouj Hijazi
November 6, 2026
3 min

MDSpire News

Objective:

The article examines the objective, findings, and clinical context described in FDA approves amivantamab for head and neck cancer.

Approach:

Treatment: Amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) is given subcutaneously as a single agent. The indication excludes HPV-associated oropharyngeal squamous cell carcinoma identified by p16 testing.
Evidence: Approval was supported by OrigAMI-4, an open-label, multicenter phase 1b/2 trial of 102 previously treated patients. Participants received weight-based treatment every 3 weeks until disease progression or unacceptable toxicity.
Assessment: The primary efficacy measure was overall response rate; duration of response was also assessed by blinded independent central review.

Key Findings:

Overall response rate was 42%: 15% complete responses and 28% partial responses.
Among responders, 56% maintained their response for at least 6 months.
Serious treatment-emergent adverse events occurred in 39% of patients; fatal adverse reactions were reported in 6%.
Common adverse reactions included rash (79%), fatigue (39%), nail toxicity (35%), stomatitis (32%), and edema (28%).

Interpretation:

The FDA granted accelerated approval based on tumor response measures rather than confirmed long-term clinical benefit. The ongoing phase 3 OrigAMI-5 trial is the confirmatory study; continued approval may depend on verification of clinical benefit.

Limitations:

OrigAMI-4 was open-label and did not directly compare amivantamab with other treatments.
The approval is accelerated, and long-term clinical benefit has not yet been confirmed.

Conclusion:

The prescribing information warns of hypersensitivity and administration-related reactions, interstitial lung disease/pneumonitis, dermatologic reactions, ocular toxicity, and embryo-fetal toxicity. Known hypersensitivity to hyaluronidase or its excipients is a contraindication.